Genentech is satisfied with the outcome, which we believe has advantages to both parties.
The arbitration panel ruling calls for unanimous Joint Development Committee approval of development plans for additional indications for certain anti-CD20 pipeline molecules. With regard to our current clinical trials in relapsing-remitting multiple sclerosis (RRMS), which have finished recruiting, we plan to work quickly with Biogen Idec to determine next steps. We hope that together we will be able to ultimately provide new options for patients with multiple sclerosis.
Through the ruling, Genentech achieved two major objectives. We maintained our freedom to continue development and commercialization of ocrelizumab in rheumatoid arthritis (RA). Additionally, the arbitrators confirmed Biogen Idec's decrease in participation in the profits of both Rituxan and ocrelizumab upon FDA approval of certain new products, such as ocrelizumab. Other points of the ruling in Genentech's favor include that we may continue with our development of ocrelizumab in lupus, Biogen Idec was denied any monetary awards despite its request, and Biogen Idec may not unreasonably withhold approval of future development plans.
The ruling also called for Genentech to stop development of certain anti-CD20 molecules in neuromyelitis optica and oncology, but these programs already had been discontinued and removed from Genentech's pipeline prior to this ruling. The decision does not impact decision-making rights related to the GA101 molecule nor does it impact development outside the co-promotion territories for Rituxan and ocrelizumab.
Genentech continues its work on four ongoing RA Phase III trials:
- STAGE, our trial investigating RA patients with an inadequate response to methotrexate (MTX), for which we completed enrollment in Q4 2008 and expect data in Q4 2009;
- SCRIPT, our study in anti-TNF inadequate responders, for which we completed enrollment in Q1 2009 and expect data in 2010;
- FEATURE, our study for MTX-inadequate responders, for which we completed enrollment in Q4 2008 and expect data in 2010; and
- FILM, our radiographic study in MTX-naïve RA patients, for which we completed enrollment in Q4 2008 and now expect data in 2011.
We also have a Phase II study for RA patients who are anti-TNF inadequate responders, CINEMA, for which we expect data in 2012.
The Phase III trial for ocrelizumab for lupus nephritis, BELONG, is expected to complete enrollment in the second half of 2009 and we expect data in 2011.
June 2009